MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Failure to Interrogate (1332); Shipping Damage or Problem (1570); Communication or Transmission Problem (2896)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.Analysis determined that the service life of the implantable neurostimulator (ins) was started prematurely.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a manufacturer representative.It was reported that the rep was getting this ins ready for a case but her tablet would not connect.She tried another tablet, tried replacing batteries in her ctm, tried an rtm/pc and could not connect.The caller states she is opting to send it back.It was reviewed with the rep that she can consider trying to use another pc/rtm if she chooses, caller stated the ins still sterile.Additional information was received from the health care provider (hcp) via a manufacturer representative on 2019-dec-30 reporting that the cause was not determined.It was unknown if the issues were resolved, there no applicable actions taken to resolve the issue.No further complications were reported.
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Manufacturer Narrative
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Correction: date of the initial mdr is 2019-12-03.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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